About this trial
The choice of skin closure (staples vs. monofilament sutures vs. barbed sutures/adhesive) is critical for wound healing quality in prosthetic surgery (hip and knee). The combination of barbed sutures (e.g., Stratafix) and skin glue (e.g., Dermabond) is promising (superior cosmetic outcome, no suture removal, antimicrobial barrier) but has been poorly evaluated prospectively and comparatively in orthopaedics, which justifies this study. The primary objective is to compare the wound healing success rate at two weeks postoperatively between the patient groups. The primary outcome measure is successful wound healing, defined as the absence of wound complications (wound dehiscence, seroma, hematoma, early postoperative infection) during the first two weeks
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women aged over 18 years
Patient who has provided written informed consent in duplicate
Patient scheduled for a primary hip or knee prosthesis implantation
BMI < 30 kg/m²
Disqualifiers
Patient expresses opposition to participating in the study
Patients under 18 years of age
Patient scheduled for prosthesis revision surgery
History of osteoarticular or soft-tissue infection
Trial design
Parallel
Treatments tested in this trial
primary knee replacement
Procedure/SurgeryFor patients who have undergone knee replacement surgery (K), the study compares the success of wound healing in surgical wounds closed with barbed sutures and adhesive (Group K1) to those closed with staples (Group K2).
Primary hip replacement.
Procedure/SurgeryFor patients who have undergone hip replacement surgery (H), the study compares the success of wound healing in surgical wounds closed with barbed sutures and adhesive (Group H1) to those closed with monofilament sutures (Group H2).
Treatment groups
Trial outcomes
Primary outcomes
Rate of Successful Wound Healing at 2 Weeks Postoperatively
Proportion of patients with successful wound healing, defined as the complete absence of wound complications (dehiscence, seroma, hematoma, or early postoperative surgical site infection) during the first 2 postoperative weeks
Secondary outcomes
Severity Stage of Wound Complications According to DISH Classification
Categorization and staging of surgical wound complications (Dehiscence, Infection, Seroma, Haematoma) based on the international Delphi consensus DISH classification scale.
Patient-Reported Scar Aesthetic Quality Score
Assessment of the scar's aesthetic quality completed by the patient using a numerical rating scale from 0 to 100, where 0 represents the worst possible aesthetic outcome and 100 represents the best possible aesthetic outcome. Higher scores indicate greater aesthetic satisfaction.
Change from Baseline in Patient Anxiety Evaluated by Visual Analog Scale (VAS)
Patient self-reported anxiety level measured on a 10-cm Visual Analog Scale (VAS) ranging from 0 to 10, where 0 represents "no anxiety" and 10 represents "extreme/worst possible anxiety". Higher scores indicate higher levels of anxiety.
Number of Unplanned Postoperative Wound-Related Medical Consultations
Total count of unplanned wound-related medical consultations (at outpatient clinics or emergency departments) per patient, as recorded in the patient follow-up logbook.
Locations
Sponsors and contacts
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